Infinity® Acute Care System (IACS) VG8.1
FDA 510(k) K260579 · Draeger Medical Systems, Inc.
510(k) numberK260579
Submission
- Device name
- Infinity® Acute Care System (IACS) VG8.1
- Applicant
- Draeger Medical Systems, Inc.
Andover, MA, US - Received
- February 20, 2026
- Decision date
- August 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…MHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/10/2026SE |
More from Shanghai Draeger Medical Instrument Co., Ltd.
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| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX · Traditional | 10/17/2023SE |
| K230278 | Babyroo TN300FMT · Traditional | 05/30/2023SE |
| K203579 | Infinity Gateway SuiteMSX · Traditional | 06/07/2022SE |
| K203088 | Infinity Acute Care System (IACS) Monitoring SystemMHX · Traditional | 02/01/2022SE |
| K201764 | Infinity Acute Care System (IACS) Monitoring SolutionMHX · Traditional | 12/09/2021SE |
| K200859 | Infinity M300MHX · Traditional | 08/28/2020SE |
| K182977 | Isolette 8000 PlusFMZ · Special | 11/21/2018SE |
Questions and answers
When was Infinity® Acute Care System (IACS) VG8.1 cleared by the FDA?
Infinity® Acute Care System (IACS) VG8.1 (K260579) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 181 days after the submission was received.
What is the product code of K260579?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.